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PubMed2000

Pharmacodynamic assessment of cefprozil against Streptococcus pneumoniae: implications for breakpoint determinations.

Cefprozil, an oral semisynthetic cephalosporin, is commonly utilized in the treatment of respiratory-tract infections in children. While this agent has provided acceptable clinical success over a number of years, this study was undertaken to better define its pharmacodynamic profile against Streptococcus pneumoniae. Nineteen clinical isolates of S. pneumoniae were utilized in the neutropenic murine thigh infection model. To simulate the pharmacokinetic profile of cefprozil in children, the renal function of mice was impaired with uranyl nitrate, and a commercially available cefprozil suspension (6 mg/kg of body weight) was administered orally every 12 h. Mice were infected with 10(6) to 10(7) CFU per thigh, and therapy was initiated 2 h later. At 0 and 24 h postinfection, thighs were harvested to determine bacterial density. Survival was assessed during 96 h of therapy. The magnitude of bacterial kill ranged from 0.5 to 4.4 log(10) CFU per thigh over 24 h, and the extent of microbial eradication was dependent on the MIC. Killing of more than 2.6 log(10) CFU per thigh was observed with MICs of < or =3 microg/ml, while either minimal killing or growth was detected with MICs of > or =4 microg/ml. Mortality in untreated control animals was 100%. Animals infected with strains for which the MICs were < or =2 microg/ml survived the infection, whereas MICs exceeding 2 microg/ml resulted in substantial mortality. These studies demonstrate the effectiveness of cefprozil against isolates of the pneumococcus for which the MICs are < or =2 microg/ml using a drug exposure typically observed in children. These data support a susceptibility breakpoint of < or =2 microg/ml for cefprozil.

Animals↗
PubMed1991

Inability of cephalothin testing to predict cefprozil susceptibility.

The 30-micrograms cefprozil disk and the cephalosporin class (30-micrograms cephalothin) disk were compared for their abilities to predict cefprozil susceptibility by agar disk diffusion testing. High error (5.02% major and 14.11% minor) rates were encountered with the cephalothin disk and were most frequently observed for Escherichia coli and Enterococcus faecalis. The cefprozil disks resulted in rates of 0.05% very major, 0% major, and 3.72% minor errors. Thus, the 30-micrograms cefprozil disk is more desirable for predicting cefprozil susceptibility.

Cephalosporins↗
PubMedDate not supplied

Antibacterial activity of cefprozil in vitro.

Cefprozil is a new orally active cephalosporin which is undergoing in vitro and in vivo evaluations. Using the standard agar dilution method we compared the in vitro activity of this drug with other oral cephalosporins and ciprofloxacin against 637 recent clinical isolates from the Kaohsiung Veterans General Hospital, Taiwan. Against Escherichia coli and Klebsiella pneumoniae, cefprozil showed good activity, inhibiting over 80% of these isolates at 8 mg/l. Like other oral drugs of its class, it had little activity against Pseudomonas aeruginosa and Acinetobacter spp. Against Haemophilus influenzae, irrespective of beta-lactamase production, its activity was similar to comparable drugs. Against methicillin-susceptible Staphylococcus aureus, cefprozil showed high activity, inhibiting 90% of these isolates at 4 mg/l, whereas against methicillin-resistant S. aureus, its activity was higher than that of other oral cephalosporins tested and was similar to that of ciprofloxacin. Of enterococci tested, 57.7% were inhibited by 8 mg/l of cefprozil. Against beta-hemolytic streptococci, its activity was superior to all other drugs tested. The results of this in vitro study indicate that oral administration of cefprozil might be efficacious in the treatment of community-acquired cutaneous, respiratory and urinary tract infections.

Bacteria↗
PubMed2004

Effect of antimicrobial therapy with amoxicillin and cefprozil on bacterial interference and beta-lactamase production in the adenoids.

To compare the effects on the bacterial flora of the adenoids of antimicrobial therapy with amoxicillin or cefprozil, we enrolled in a prospective randomized study 60 children scheduled for elective adenoidectomy because of recurrent otitis media. They were randomized before surgery into 3 groups of 20 patients each: a no-therapy group, and groups with 10 days of either amoxicillin or cefprozil therapy. Core adenoid materials were quantitatively cultured for aerobic and facultative bacteria. The in vitro ability of alpha-hemolytic streptococci (AHS) to inhibit the growth of non-type B Haemophilus influenzae and Streptococcus pneumoniae was determined. The number of organisms in adenoids obtained from patients treated with either antibiotic was reduced as compared to that in adenoids from controls. However, in patients treated with amoxicillin, a significant decline in the number of AHS, and an increase (in Staphylococcus aureus) or no change in the number of other beta-lactamase-producing bacteria (BLPB) was noted. In contrast, in those treated with cefprozil, no change was noted in the frequency of recovery of AHS, and the number of BLPB decreased. Interfering AHS were more often recovered in patients treated with cefprozil. We conclude that the adenoids contain more interfering AHS after therapy with a second-generation oral cephalosporin (cefprozil) than after amoxicillin therapy. This study suggests a potential beneficial effect of using an antimicrobial that selectively spares interfering AHS while inhibiting BLPB.

Adenoids↗
PubMed2004

Comparison of trimethoprim-sulfamethoxazole, cephadroxil and cefprozil as prophylaxis for recurrent urinary tract infections in children.

The aim of this study was to compare the efficacy of prophylactic trimethoprim-sulfamethoxazole (TMP/SMZ), cefprozil and cephadroxil treatments in children who have recurrent urinary tract infection, but no urinary tract pathology. After acute urinary tract infections (UTIs) were treated, the patients were divided into 3 groups randomly and TMP/SMZ was given to 21 patients, cephadroxil was given to 25 patients and cefprozil was given to 34 patients for 3 months--one dose at night. All patients were followed for 6 months following prophylaxis. The frequency of symptomatic UTIs among groups during prophylaxis was not statistically different, however the number of symptomatic UTIs in the cephadroxil group was lower than the other groups. Asymptomatic bacteriuria episodes were detected in TMP/SMZ and cefprozil groups, whereas no asymptomatic bacteriuria episodes were seen in the cephadroxil group. The number of patients with symptomatic UTI during the follow-up period was not different between groups, however all the asymptomatic bacteriuria episodes were encountered in the cefprozil group. In conclusion, in this study cephadroxil was found to be slightly superior to TMP/SMZ and cefprozil in preventing asymptomatic bacteriuria episodes and symptomatic UTIs in children with recurrent UTI and normal urinary tract system.

Administration, Oral↗
PubMed1993

Effects of time of administration and posture on the pharmacokinetics of cefprozil.

The effects of time of administration, sleep and posture on the pharmacokinetics of cefprozil were evaluated in a single-dose 3-way crossover study. After a 6-hour fast, 12 healthy male volunteers received oral cefprozil 250mg at 1200h (treatment A), 1200h (treatment B) and 2400h (treatment C) with a 7-day washout interval between each treatment. During the study period, volunteers receiving treatment A remained in a sitting/standing position or were ambulatory, those receiving treatment B were in the supine position, and those receiving treatment C were sleeping. Blood samples were taken over an 8-hour period and the plasma samples were analysed for the concentrations of cefprozil by a high performance liquid chromatography-ultraviolet method. Plasma concentration vs time data were analysed using noncompartmental analysis methods. Mean peak plasma concentrations (Cmax) were 4.51, 5.02 and 4.91 mg/L for treatments A, B and C, respectively. Corresponding mean values of the area under the plasma concentration-time curve (AUC(0-infinity)) were 12.6, 12.6 and 14.2 mg/L.h, respectively. The mean half-life (t1/2) values were 1.30, 1.23 and 1.50 hours for treatments A, B and C, respectively. Mean AUC(0-infinity), Cmax and t1/2 values following treatment B were not significantly different from those of treatment A. However, the mean AUC(0-infinity) and t1/2 values of cefprozil following treatment C were significantly greater than those of either treatment A or B. The mean Cmax value following treatment C was not significantly different than that of either treatments A or B. From these results, it was concluded that posture has no effect on the pharmacokinetics of cefprozil.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMedDate not supplied

A noncomparative study of cefprozil at two dose levels in the treatment of acute uncomplicated bacterial sinusitis.

The efficacy and safety of cefprozil at two dose levels were evaluated in 110 patients with acute uncomplicated bacterial sinusitis in an uncontrolled, noncomparative, Phase II trial. Ninety patients received 250 mg of cefprozil (low-dose group) and 20 patients received 500 mg of cefprozil (high-dose group) every 12 hours for ten days. Evaluable patients had symptoms consistent with acute sinusitis, pathogens isolated at pretreatment susceptible to cefprozil, and a radiograph positive for sinusitis within 48 hours before treatment. A satisfactory clinical response was achieved in 34 of 39 evaluable patients (87%) in the low-dose group and in all 16 evaluable patients (100%) in the high-dose group. Pathogens were eradicated in 35 of 39 patients (90%) in the low-dose group and in 15 of 16 patients (94%) in the high-dose group. A total of 140 of 155 pathogens (90%) isolated pretreatment were susceptible to cefprozil. Six patients (7%) in the low-dose group and one patient (5%) in the high-dose group reported at least one adverse clinical event.

Adolescent↗
PubMedDate not supplied

In vitro activity of clarithromycin, cefprozil, and other common oral antimicrobial agents against gram-positive and gram-negative pathogens.

Macrolide and beta-lactam antimicrobial agents are frequently used for the treatment of upper and lower respiratory tract infections and skin or skin structure infections. To evaluate the relative in vitro activity of these antimicrobial drugs against organisms commonly involved in these infections, we tested clarithromycin, erythromycin, cefprozil, cefuroxime, cefaclor, cephalexin, amoxicillin, amoxicillin/clavulanate, and doxycycline against 174 gram-positive and gram-negative clinical isolates, including Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, group A beta-hemolytic streptococci, alpha-hemolytic streptococci, Escherichia coli, and Klebsiella pneumoniae. Manual broth microdilution susceptibility testing was used with a standard inoculum of 5 x 10(4) colony-forming units/well at pH of 7.2. Clarithromycin was the most active agent against streptococci. Methicillin-susceptible S aureus exhibited resistance to both clarithromycin and erythromycin, but was susceptible to cefprozil, cefuroxime, amoxicillin/clavulanate, and doxycycline. Cefprozil was at least as active as cefuroxime, cefaclor, and cephalexin against all organisms tested, but was fourfold less active than doxycycline against E coli and 16-fold less active than clarithromycin versus S pneumoniae. The gram-negative isolates tested showed resistance to clarithromycin and erythromycin; however, cefprozil was as active as amoxicillin/clavulanate against K pneumoniae and E coli. These results demonstrate that clarithromycin provides superior in vitro activity against common streptococci, while cefprozil, cefuroxime, amoxicillin/clavulanate, and doxycycline provide greater activity against methicillin-susceptible S aureus, K pneumoniae, and E coli. Prospective clinical trials are needed to determine the clinical significance of these findings.

Anti-Bacterial Agents↗
PubMed2003

Cefprozil: a review.

Cefprozil is a novel third generation, broad-spectrum oral cephalosporin with activity against a spectrum of aerobic gram-negative and positive bacteria, as well as certain anaerobes. The beta-lactamase stability of cefprozil may exceed that of other oral cephalosporins for some important pathogens. Cefprozil may be a suitable alternative to several other commonly used beta-lactams and cephalosporins in the treatment of mild to moderate upper and lower respiratory tract infections including sinusitis, otitis media, pharyngitis/tonsillitis, secondary bacterial infection of acute bronchitis, and acute bacterial exacerbations of chronic bronchitis, and skin and skin structure infections in children. Available data indicate the safety of cefprozil in both pediatric and adult population.

Bronchitis↗
PubMed1997

Effect of penicillin or cefprozil therapy on tonsillar flora.

The effect on the tonsillar bacterial flora of antimicrobial therapy with penicillin or a second-generation cephalosporin (cefprozil) was studied. Sixty children scheduled for elective tonsillectomy because of recurrent group A beta-haemolytic streptococcal tonsillitis participated in a prospective randomized study that divided them into three groups. One group received no therapy, and the others were given either penicillin or cefprozil for 10 days prior to surgery. The core of the patients' tonsils was cultured for aerobic bacteria. Group A beta-haemolytic streptococci (GABHS) were isolated from 15/20 (75%) of untreated, 11/20 (55%) of penicillin, and 2/20 (10%) of the cefprozil group (P < 0.001). Thirty-two beta-lactamase-producing bacteria were recovered from 19/20 (95%) of untreated, 33 from 17/20 (85%) treated with penicillin and six from 4/20 (20%) treated with cefprozil (P < 0.01). Alpha-haemolytic streptococci (AHS) inhibiting GABHS were less often isolated from patients treated with penicillin. These data illustrate the ability of a second-generation cephalosporin to eradicate GABHs, as well as beta-lactamase-producing bacteria, while preserving AHS.

Adolescent↗
PubMed1990

Pharmacokinetics of cefprozil in infants and children.

Twenty pediatric patients (ages, between 8 months and 8 years) received a single oral dose of cefprozil at levels of 15 and 30 mg/kg of body weight. Cefprozil consists of cis (BMY-28100) and trans (BMY-28167) isomers in an approximately 90:10 ratio. Six plasma samples were collected from each pediatric patient and assayed for drug concentrations. As measured by a microbiological assay, peak concentrations of 11.16 and 15.93 micrograms of cefprozil per ml occurred at 1 h for patients who received the 15- and 30-mg/kg doses, respectively. The respective mean half-lives of cefprozil were 1.77 and 2.14 h, and the respective mean areas under the curve were 28.05 and 45.28 micrograms.h/ml for patients who received the 15- and 30-mg/kg doses. When measured by a high-pressure liquid chromatography method, peak concentrations of 12.09 and 18.04 micrograms of the cis isomer per ml were obtained at 1 h, with mean half-lives of 1.63 and 2.06 h and mean areas under the curve of 30.48 and 49.34 micrograms.h/ml in patients who received the 15- and 30-mg/kg doses, respectively. For the trans isomer, peak concentrations of 1.16 and 1.63 micrograms/ml occurred at 1 h, respectively, with mean half-lives of 1.61 and 1.65 h and mean areas under the curve of 2.89 and 4.34 micrograms.h/ml in patients who received the 15- and 30-mg/kg doses, respectively.

Administration, Oral↗
PubMed1991

Pharmacokinetics of cefprozil in healthy subjects and patients with renal impairment.

Cefprozil, a new broad-spectrum oral cephalosporin, is composed of cis and trans isomers in an approximate 90:10 ratio. The pharmacokinetics of a single oral 1000-mg dose of cefprozil were evaluated in 6 healthy subjects and 24 patients with various degrees of renal impairment. Six of these subjects were studied both while receiving hemodialysis and during an interdialytic period. Plasma, urine, and hemodialysate that were collected at predetermined times were analyzed for concentrations of the cis and trans isomers of cefprozil using reverse-phase HPLC assay with UV detection. The maximum plasma concentration of the cis isomer ranged from 12.3 micrograms/mL in subjects with normal renal function to 36.7 micrograms/mL in hemodialysis patients. Similarly the area under the plasma concentration-time curve and the elimination half-life increased from 46 micrograms.h/mL to 373 micrograms.h/mL and from 1.72 hours to 5.94 hours, respectively. Renal clearance of the cis isomer decreased from 198 mL/min in normal subjects to 19 mL/min in volunteers with creatinine clearances of less than or equal to 30 mL/min; there was a strong correlation (r2 greater than or equal to .93) between the renal clearance of the cis isomer and creatinine clearance. Urinary recovery of the cis isomer decreased from 57% in those with normal renal function to 24% in the group with a creatinine clearance of less than or equal to 30 mL/min. Hemodialysis decreased the half-life of the cis isomer to 2 hours and removed approximately 55% of it from the body during a 3-hour dialysis period (hemodialysis clearance equaled approximately 87 mL/min). The pharmacokinetics of the trans isomer were similar to those observed for the cis isomer and were affected similarly by declining renal function. A reduction in dosage is recommended in patients with a creatinine clearance of 30 mL/min or less. It may be necessary to administer a dose after hemodialysis to maintain therapeutic plasma concentrations.

Administration, Oral↗
PubMed1991

Pharmacokinetics of cefprozil in healthy subjects and patients with hepatic impairment.

The pharmacokinetics of cefprozil were studied in 12 (9 men, 3 women) subjects with hepatic impairment and in 12 healthy subjects who were matched for age, sex, and weight. Each subject received a single 1000 mg oral dose of cefprozil, which consists of cis and trans isomers in approximately a 90:10 ratio. Serial blood and urine samples were collected and analyzed using validated HPLC/UV methods for the concentration of each isomer. The results of the plasma and urine analyses were subjected to noncompartmental pharmacokinetic analysis. The values for the peak plasma concentrations (Cmax), area under the plasma concentration versus time curve (AUC0-infinity), apparent total body clearance (Clt/F), renal clearance (Clr), and percent of drug excreted in urine (%UR) of each isomer were not significantly different in healthy subjects and patients with hepatic impairment. The only parameters that were significantly (P less than or equal to .05) longer in patients with hepatic impairment were mean residence time in the body (MRT) and half-life; the MRT for the cis isomer in healthy subjects and subjects with hepatic impairment were 3.33 hr and 3.88 hr, respectively, and for the trans isomer 3.17 hr and 3.68 hr; the half-life for the cis isomer was 1.62 hr and 2.22 hr, respectively, and for the trans isomer 1.21 hr and 1.54 hr. The pharmacokinetics of the cis and trans isomers of cefprozil were virtually identical in healthy subjects as well as those with hepatic impairment.

Administration, Oral↗
PubMed1997

Five-day versus ten-day treatment of acute otitis media with cefprozil.

A randomized comparative clinical trial was conducted to investigate the possibility of decreasing the duration of treatment of acute otitis media by comparing the clinical outcome and safety of a five-day and a ten-day course of cefprozil. A total of 708 pediatric patients were enrolled in the study, 560 of whom were evaluable for efficacy. Cefprozil was found to be completely effective in 87.1% of cases after five days of treatment, and in 91.2% after ten days of treatment. Of 19 patients with three or more previous episodes of acute otitis media, ten patients in the ten-day treatment group had a 100% cure rate, while in the five-day group four experienced cure, three improvement, and two failure. A five-day course of treatment with cefprozil can be recommended only if children have no history of recurrent acute otitis media.

Acute Disease↗
PubMed1991

Simultaneous high-performance liquid chromatographic analysis of cefprozil diastereomers in a pharmacokinetic study.

Cefprozil, a new oral cephalosporin, consists of a 90:10 cis:trans isomer mixture. Sensitive, specific and reproducible high performance liquid chromatographic methods have been developed for the simultaneous quantification of the two stereoisomers of cefprozil in plasma and urine samples from human and rats. Cephalexin acted as the internal standard. Plasma protein was precipitated with acetonitrile and trichloracetic acid with subsequent extraction of acetonitrile. After vortexing and centrifuging, the aqueous phase was injected onto a reverse phase C8 column. Urine samples were acidified with sodium acetate buffer (pH 3.8) and then directly injected onto a reverse phase C18 column. The detector was set at 280 nm. These methods were applied to determine protein binding of both isomers in human and rat sera, and to perform a pharmacokinetic study in human. Results showed that both isomers bound moderately to serum proteins with no interference by the other isomer. The pharmacokinetic study in human indicated that cefprozil was well absorbed and the cis and trans isomers have similar pharmacokinetics.

Animals↗
PubMed1992

Clinical trials of cefprozil for treatment of skin and skin-structure infections: review.

Limitations of currently used antimicrobial agents for the treatment of skin and skin-structure infections (e.g., increased resistance to penicillin and erythromycin and inconvenient dosing schedules) have led to an adjustment in the kinds of antimicrobial agents prescribed for these diseases. Three recently completed clinical studies have demonstrated some therapeutic advantages of cefprozil, a new broad-spectrum oral cephalosporin, over cefaclor and erythromycin in the treatment of skin and skin-structure infections. Specifically, cefprozil offers clinical efficacy equivalent to those of cefaclor and erythromycin both at lower total doses and on a less frequent dosing schedule (once or twice daily vs. three to four times daily). The advantage of once-daily or twice-daily dosing with cefprozil may contribute to patient convenience and compliance.

Cefaclor↗
PubMed1997

Cefprozil treatment of persistent and recurrent acute otitis media.

OBJECTIVE: We identified the pathogens causing persistent and recurrent acute otitis media (AOM) and the clinical efficacy of cefprozil as treatment. STUDY DESIGN: This was a noncomparative, open label multicenter trial. Children ages 6 months to 12 years with signs and symptoms of AOM and evidence of middle ear effusion, as confirmed by pneumatic otoscopy or tympanometry, underwent tympanocentesis and subsequent treatment with cefprozil (15 mg/kg given twice daily) for 10 days. Patients with recurrent otitis media or failure of previous antibiotic therapy or prophylaxis were particularly sought for the study. RESULTS: Two hundred sixty-two (99%) of 265 enrolled children were considered evaluable. The median age of the study group was 1 year. Ninety-eight (37%) of the children had a history (within 30 days) of prior antibiotic use. Ninety-seven (37%) met our definition of recurrent AOM, 48 (18%) met our definition of persistent AOM and 132 (50%) children had 3 or more previous episodes of acute otitis media within 12 months before study. Eighty-two (31%) of the enrollment tympanocentesis had no growth, 150 (57%) had a single bacterial pathogen and 29 (11%) had multiple bacterial pathogens. Of the 93 Streptococcus pneumoniae pretreatment isolates, 50 (54%) were penicillin-susceptible, 12 (13%) were penicillin-intermediate resistant and 31 (33%) were penicillin-resistant. Of the 75 Haemophilus influenzae pretreatment isolates, 42 (56%) produced beta-lactamase as did 4 (27%) of the 15 Moraxella catarrhalis strains. A satisfactory clinical response by pathogen was found in 75% (70 of 93) with S. pneumoniae, 75% (56 of 75) with H. influenzae and 93% (13 of 14) with M. catarrhalis; the response with single pathogen infections was higher than those with multiple pathogens (118 of 150 (78%) and 17 of 29 (59%), respectively; P = 0.03). The response for patients with isolates of S. pneumoniae that were penicillin-susceptible, -intermediate or -resistant were 39 of 50 (78%), 11 of 12 (92%) and 21 of 31 (68%), respectively. Older children had a satisfactory clinical outcome more frequently than younger children (P < 0.001), and the response to therapy varied for persistent, recurrent and recently untreated AOM (P < 0.01). CONCLUSION: Persistent and recurrent AOM involves the same pathogens as recently untreated AOM but bacteria with reduced antibiotic susceptibility may be more frequently present. This noncomparative study suggests that cefprozil 30 mg/kg/day given in two divided doses for 10 days may be effective in the treatment of children with persistent and recurrent AOM.

Acute Disease↗
PubMed1991

Comparison of cefprozil and cefaclor for treatment of acute urinary tract infections in women.

A total of 108 college women with acute urinary tract infections were treated for 10 days with either 500 mg of cefprozil (BMY-28100-03-800) once a day (n = 72) or 250 mg of cefaclor three times a day (n = 36). Clinical and bacterial cure rates at 1 week posttherapy were 94 and 93%, respectively, for the cefprozil group and 94 and 94%, respectively, for the cefaclor group (P, not significant). Both cefprozil and cefaclor were safe and effective.

Acute Disease↗